UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044086 |
|---|---|
| Receipt number | R000048955 |
| Scientific Title | Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/05/01 08:13:06 |
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Basic information
Public title
Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Acronym
Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Scientific Title
Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Scientific Title:Acronym
Effects of lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke: a randomized controlled trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the lateral seated reaching exercise on functional outcomes for low sitting performance in early sub-acute stroke
Basic objectives2
Others
Basic objectives -Others
To analyse the trunk muscle activity during lateral seated reaching task in stroke patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Function in sitting test
Outcomes are evaluated before-intervention, 1 and 3 weeks after intervention
Key secondary outcomes
Postural Assessment Stroke Scale (PASS)
Trunk impairment scale (TIS)
Stroke Impairment Assessment Set (SIAS)
Scale for Contraversive Pushing (SCP)
Burke Lateropulsion Scale (BLS)
Lateral sitting balance
Outcomes are evaluated before-intervention, 1 and 3 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The experimental group 1 sit without leg support on a horizontal surface. The subjects were asked to move their trunk to non-paretic side. This training program is performed 40 times per session, with 4 to 6 sessions in 1 weeks. In addition, the subjects receive conventional physiotherapy.
Interventions/Control_2
The experimental group 2 sit without leg support on a surface tilted 10 degrees to paretic side. The subjects were asked to move their trunk to non-paretic side. This training program is performed 40 times per session, with 4 to 6 sessions in 1 weeks. In addition, the subjects receive conventional physiotherapy.
Interventions/Control_3
Control group perform conventional physical therapy.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) within 30 days from onset
2) infarction of hemorrahage
3) over 20 years old
4) sitting is not independently
5) stable neurological symtome
6) ability to undertand instructions
Key exclusion criteria
1)none of the above
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
0429844367
fkazuhiro.68@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Fukata |
Organization
Saitama Medical University International Medical Center
Division name
Department of rehabilitation center
Zip code
350-1298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
+81429844367
Homepage URL
fkazuhiro.68@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (KAKENHI)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
Tel
0429844367
imc_irb@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048955
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